ONEvite: Package Insert and Label Information

ONEVITE- ascorbic acid, cholecalciferol, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine, folic acid, cyanocobalamin, biotin, calcium pantothenate, vitamin a acetate, vanadyl sulfate, .alpha.-lipoic acid and lutein tablet
NEOMED PHARMACEUTICAL

Each Tablet Contains:

tab1
(click image for full-size original)

Other Ingredients: Di calcium phosphate, microcrystalline cellulose, croscarmellose sodium, stearic acid, silicon dioxide, titanium dioxide, PEG 8000, magnesium stearate, talc, HPMC E15 & HPMC E5/E6

INDICATIONS AND USAGE

ONEvite Tablets is an orally administered prescription vitamin supplement specifically formulated for the clinical dietary management of patients with unique nutritional needs requiring, increased folate levels and nutritional supplementation in physiologically stressful conditions. As well as for maintenance of good health and beneficial in maintaining overall skin health, also help maintain healthy blood sugar levels and help promote nerve health and function including normal vision.

CONTRAINDICATIONS

ONEvite Tablets is contraindicated in patients with hypersensitivity to any of its components. Folic Acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.

Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (Vitamin B12).

WARNING/PRECAUTIONS

Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur.

Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.

The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.

Avoid Over dosage. Keep out of the reach of children.

Drug Interactions

High doses of folic acid may result in decreased serum levels of anticonvulsant drugs.

Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

Consult appropriate references for additional specific vitamin-drug interactions.

Information for Patients

Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breastfeeding.

Pediatric Use

Not recommended for pediatric use.

ADVERSE REACTIONS

Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in ONEvite T ablets

DOSAGE AND ADMINISTRATION

ONEvite Tablets is a white film coating with caplet shape.

One tablet daily or as directed by a physician.

HOW SUPPLIED

ONEvite Tablets available 90 tablets per bottle,

70898-198-09

Store at room temperature 15°-30°C (59°-86°F). Avoid excessive heat and moisture.

To report a serious adverse event or obtain product information, call 631-524-5758

Manufactured for:

Neomed Pharmaceutical

Brentwood, NY 11717

www.neomedpharmaceutical.com

MADE IN USA

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

image description
(click image for full-size original)

ONEVITE
onevite tablet
Product Information
Product Type Item Code (Source) NDC:70898-198
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 125 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 10 ug
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 1.5 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.7 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 12.5 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1000 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 1000 ug
BIOTIN (BIOTIN) BIOTIN 300 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 10 mg
VITAMIN A ACETATE (VITAMIN A) VITAMIN A 1500 ug
VANADYL SULFATE (VANADIUM) VANADYL SULFATE 200 ug
.ALPHA.-LIPOIC ACID (.ALPHA.-LIPOIC ACID) .ALPHA.-LIPOIC ACID 100 mg
LUTEIN (LUTEIN) LUTEIN 1 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
STEARIC ACID
SILICON DIOXIDE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 8000
MAGNESIUM STEARATE
TALC
HYPROMELLOSES
Product Characteristics
Color white Score no score
Shape OVAL Size 4mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70898-198-09 1 BOTTLE in 1 PACKAGE contains a BOTTLE
1 90 TABLET in 1 BOTTLE This package is contained within the PACKAGE (70898-198-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 12/01/2018
Labeler — NEOMED PHARMACEUTICAL (048388130)

Revised: 06/2019 NEOMED PHARMACEUTICAL

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